Perspectives on Current Attitudes, Enablers, and Barriers to Obtaining Surgical Informed Consent for Doctors-in-Training

Background Surgical informed consent (SIC) is paramount in modern-day litigious surgical practice, yet numerous complaints remain about the consenting process. This paper investigated current attitudes, enablers, and barriers to obtaining SIC in clinical practice for doctors-in-training (DiT). Methodology Self-reported SIC practice among DiT (N=1,652) across three metropolitan health service regions in Western Australia (WA) was surveyed using a de-identified 20-item multiple response ranking, dichotomous quantitative and qualitative online survey. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 27 (IBM Corp., Armonk, NY, USA). Results The response rate was 23% (n=380). There was an even distribution of key demographics across all three health regions; the median postgraduate year (PGY) was two. Only 57.4% of DiT strongly felt comfortable and confident obtaining a SIC. Of the responders, 67.4% correctly identified key SIC components. There were significant positive associations between comfort and confidence with obtaining SIC and the seniority level of the DiT (p<0.001), identification of SIC components (p<0.001), and prior training in SIC (p<0.001). Most DiTs highlighted the necessity for formal SIC training with a preference for interactive workshops supported by e-learning modules. Conclusions Most DiTs can identify the key factors that constitute a valid SIC; however, the practical conversion of this skill could be better. The key enablers to improved SIC techniques were well-supported departments, with further training and clear guidelines within the institutions. The identified barriers were time constraints, inexperience, and a lack of senior support. Future practices and interventions should address these key barriers while promoting the enablers of sustainable and efficient SIC practice.


Introduction
Surgical informed consent (SIC) is paramount in modern-day litigious surgical practice. The balance of legal and ethical paradigms makes obtaining informed consent challenging while ensuring appropriate discussion of risks, including material risks. A material risk is one in which, in a particular case, a reasonable person in the patient's position would likely attach significance [1,2]. The shift in focus from a doctor-centered view (also known as the Bolam principle, a medical ethos founded on trust and the assumption that "doctor knows best") to the current model of SIC (with a focus on "reasonable patient standard") was changed in Australia due to several medicolegal cases, the most prominent of which was the Rogers versus Whitaker case in 1992 [1].
The Rogers versus Whitaker case describes Whitaker having a complication from ophthalmic surgery resulting in sympathetic ophthalmia in her unaffected eye, causing her to become blind in both eyes. Despite this risk being 1:14,000, the High Court deemed it a "material risk to the patient," considering it an essential material risk that her surgeon should have discussed as part of the duty of care. As such, the current position is that the doctor "must warn a patient of a material risk inherent in the proposed treatment" [2]. Despite this precedent set for three decades, the medical indemnity services still report that close to 12% of complaints are related to the consenting process [3].
This article was previously presented as a meeting abstract at the 2021 Royal Australasian College of Surgeons Annual Scientific Congress (ASC) on May 11th, 2021, in Melbourne and May 6th, 2019, in Bangkok.

Study population
In Australia, the natural progression of the medical career begins as an intern, then a resident, registrar, fellow of a specialty college, and finally, a consultant. An intern is a postgraduate year 1 (PGY1) doctor with provisional registration. A resident is at least PGY2 and possesses general registration. A registrar is usually PGY3 and above and can be accredited by a specialty college, meaning undergoing specialist training. Registrars not enrolled in an advanced specialist training program are referred to as unaccredited or service registrars. Registrars supervise both interns and residents. This paper acknowledges that the role and level of resident and registrar as defined in Australia may differ internationally; therefore, the postgraduate year level associated with these roles may help the readers match their own system. All 1,652 doctors-in-training (DiT) interns (n=322), residents (n=761), registrars (n=484), and fellows (n=85) from three metropolitan regions in Western Australia (WA) were invited via multimedia formats (email, hyperlinks, and QR codes on societies' social media sites and at grand rounds and teaching sessions) to participate in an online, de-identified survey. The self-reported SIC practice survey was conducted between September 2018 and March 2019 and contained a mix of dichotomous (yes/no), multiple responses, and free text completion items (Appendices: Supplemental online materials -pipetted survey questionnaire). Multiplatform reminders were sent to improve the response rate. Essential components such as participants' comfort and confidence levels with obtaining SIC were assessed using a 5-point Likert scale.

Statistical analysis
Baseline characteristics and self-reported practice were described using mean (± standard deviation), median (interquartile range), and frequencies/proportions as appropriate. Outcomes for continuous unpaired variables were analyzed with the nonparametric Mann-Whitney U test. Dichotomous outcomes were compared between groups using χ2 or Fisher's exact tests with no adjustment for multiple comparisons. For the primary outcome, the relative comfort and confidence in obtaining a SIC was captured using the Likert scale and expressed as a proportion and 95% confidence interval. A secondary analysis of the primary outcome was performed using univariate analysis to assess significant associations. The correlation between two quantitative variables was evaluated using Spearman's rank correlation test. All analyses were performed using Statistical Package for the Social Sciences (SPSS) version 27 (IBM Corp., Armonk, NY, USA), and a two-tailed p-value of <0.05 was considered statistically significant.

Ethics
This project was approved as a quality improvement project of negligible risk with authority to publish by the lead Human Research Ethics Sub-Committees on Safety, Quality Improvement, and Governance (reference #28025, 28098). All participants provided informed consent for the publication of their deidentified data.

Demographics
The response rate was 23% (n=380), with equal distribution of key demographics across all three health regions. Most respondents were between postgraduate years 1 and 4, with the majority being residents. Two-thirds of respondents had no prior SIC training. Of those with training, 42.1% received it in medical school. Most respondents agreed or strongly agreed that formal SIC training was necessary. In addition, 67.4% understood the essential components of SIC, with most (85%-92%) correctly identifying separate components of SIC (

SIC practice
This survey shows that DiTs have good self-reported practices in obtaining SIC. Most routinely check for competency and discuss key tenants such as diagnosis, indications, risks, benefits, potential complications, and alternative management options. However, only 57.4% of the respondents felt comfortable or confident obtaining SIC ( Table 3).

Variable Proportion Number
In elective cases, when is the best time/location to obtain SIC?

Univariate analysis
Univariate analysis showed significant positive associations between comfort/confidence with getting SIC and seniority (p<0.001), identification of SIC components (p<0.001), and prior training in SIC (p<0.001).
Participants who had no formal training or had training in obtaining SIC during their internship were less comfortable/confident in obtaining SIC (p<0.001). There was no significant association between comfort and confidence in obtaining SIC and gender (p=0.581) (  Furthermore, the univariate analysis also showed significant positive associations between the correct identification of SIC components and seniority (p<0.001), with more participants being able to identify these components correctly as their experience level increased. This was also true for gender (p<0.001), with females more likely to identify components correctly. The speciality of interest did not influence this. Participants who received formal SIC training were more likely to identify SIC components than those who did not (p<0.001). Of interest, participants who only underwent SIC training as interns demonstrated similar (poor) proportions of accurately identifying the components of a SIC (p<0.001) ( Table 4).

Barriers and enablers
The critical enablers identified in the qualitative informants' analysis included having previous training in SIC and working in well-supported departments with clear guidelines on SIC. The barriers highlighted were inexperience with SIC (especially when consenting for other specialities or unfamiliar procedures), time constraints, and the need for senior support ( Table 5).

Enablers Barriers
Well-supported departments Inexperience with SIC

Previous training in SIC Time constraints
Clear guidelines on SIC Lack of senior support

TABLE 5: Enablers and barriers to obtaining SIC for respondent DiT
Values are the number of participants (%) unless otherwise indicated.

Thematic analysis
A comprehensive logarithmic qualitative thematic analysis of free text item perspective responses was conducted. A pictorial representation of the key informants on enablers and barriers is demonstrated in Figure 1.

Discussion
Obtaining an adequate SIC can be a complex and detailed process, the responsibility of which often befalls junior doctors in busy hospital settings, a homogenous observation between studies [10]. All clinicians have a moral and ethical obligation to engage fully in the SIC process, a conversation they ought to have with patients to ensure consistent delivery of individualized, safe, culturally sensitive, and appropriate healthcare. Poor SIC practices may expose the DiT to medicolegal risk, potentially causing patient harm. All stakeholders must actively engage in the SIC process to achieve appropriate shared decision-making.
This study shows that a significant proportion of SIC needs to be executed to the required legal standard (including disclosing relevant material risks), placing DiTs in a tenuous medicolegal predicament. It also reflects that DiTs may fall short of their duty of care when patients cannot fully participate in decisionmaking. This is further highlighted by the fact that while most DiTs who responded had SIC training in medical school, only a minority could adequately identify all the SIC components. Repeated SIC training may be more valuable when the DiTs are more experienced as they have better contextual understanding.
An alarming statistic showed that only half of the respondents felt confident and comfortable with the SIC process, further highlighting that we must do better in supporting DiTs. It demonstrates that DiTs may be acquiring consent despite feeling inadequate or experienced. Other studies have identified that DiTs may feel "pressured" to perform their job or meet expectations without "troubling" senior members, all to be considered competent [7]. The observed trend of improved confidence/comfort with SIC as doctors advance in seniority results from repeated exposure and experience, especially in a surgical-specific role. As part of the surgical team, DiTs' experiences and learning increase exponentially through direct observation and practice, thus enhancing understanding and active engagement with the SIC process. During this period, as DiTs undergo this learning curve, they must be provided support, learning resources, and opportunities to solidify their experiences and knowledge of the SIC. By understanding the essential components of the SIC, DiTs can rely on their learned experiences and previous exposure when faced with unfamiliar or challenging situations, transferring these skills in situations like emergencies or where a patient is not competent.
"See one, do one, teach one" is a fundamental concept in Halsted's model that surgeons alike are all too familiar with. Informal learning can be fostered by observing senior doctors perform SIC or, conversely, having senior doctors watch and critique junior doctors performing SIC. However, it is not a universally equal or reliable teaching method across hospital teams as it depends on time availability and the skillset of individual doctors. Formal training will improve SIC component familiarity and comfort/confidence in obtaining SIC. This could be done through professional skills workshops such as the Training in Professional Skills (TIPS) offered by the Royal Australasian College of Surgeons or hospital-based simulation skills workshops that allow for formal constructive feedback after observing DiTs performing these tasks. These opportunities should not be administrative-mandated learning modules as these tend to disengage learners [7]. There is a pressing need for a global initiative to standardize the education and training instruction of the SIC process as we move away from a paternalistic model to autonomous patient care, bearing in mind local cultural differences worldwide.
There are certain limitations to this study. Overall, the response rate for the survey was low at 23%. At the same time, low survey response rates are not uncommon, especially in surveys involving healthcare professionals [11][12][13]. This may reflect a level of response bias in our results. DiTs who felt strongly about SIC were likelier to participate, resulting in an over-representation of the cohort. An important observation from the study is that most respondents were comprised of junior doctors, i.e., interns and residents. Despite the low response rate, the study captured responses from the most susceptible group of junior doctors, early in their careers and often tasked with a realm of responsibilities, including obtaining consent.
To improve response rates, reminders at various periods could be sent out to prompt responses or provide small incentives for completing the surveys. Another option is to liaise with the institutions' education officers to promote completing such surveys at the start of continuous professional development sessions. The study also included self-reported clinical practice, as assessing each documented consenting process for each respondent in the survey would be impractical. As such, the study would not be able to determine the competence of the DiT, with potential gaps between the DiTs' confidence/comfort/skill with SIC and their basic skills in SIC.
Qualitative studies such as surveys are inherently prone to recall bias; for example, in this study, many DiTs reported not receiving formal training in obtaining SIC, which could be true. On the contrary, possibilities may include simply not remembering prior education in this area, particularly in cases of significant time lapse between education and undertaking the survey or where education received was considered inadequate. Lastly, this study did not analyze nor identify where respondents initially trained, with overseas trainees unlikely to be familiar with the nuances of the Australian medicolegal system compared to their domestic counterparts. In addition, different medical schools may vary in their approaches and emphasis on SIC training, leading to differences observed in the regions. This necessitates the pressing need for a global initiative to standardize the education and training instruction of the SIC process as we move from a paternalistic model to autonomous patient care.

Conclusions
This study highlights the need for ongoing support and education for DiTs performing SIC. There is a greater need to emphasize SIC training, education, and practice beginning in medical school and then reinforced in clinical practice. Health institutions play an integral role in supporting DiTs in developing good SIC practices through regular training and providing access to clear guidelines. When clinicians and patients engage well in SIC, shared decision-making occurs, leading to individualized, safe, culturally sensitive, and appropriate healthcare delivery. A workforce well versed in the intricacies of the SIC process in tandem with a well-informed patient population will contribute to a sustainable healthcare system with consistent good health outcomes.  Q16. I would like to receive an executive summary of the research findings. 0 = Yes or 1 = No Q17. If you answered yes to the above question, please provide your preferred email address for correspondence: The contact details provided will be extracted separately from the study data to maintain anonymity.
Please note that this research group takes your confidentiality very seriously.
At no time will the raw data collected in this survey be released to any third party.
Thank you for taking the time to complete this survey. It is greatly appreciated! End of the survey.
https://www.surveymonkey.com/r/SICWA  ). This project was approved as a quality improvement project of negligible risk with authority to publish by the Safety, Quality Improvement and Governance Office (reference #28025, 28098). As only adult subjects were included, informed consent was obtained from all subjects. All methods were carried out in accordance with relevant guidelines and regulations. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.